More Data Needed To Justify Risks and Costs of IVC Filters

MedicalResearch.com Interview with:

David L. Brown, MD, FACC Professor of Medicine Cardiovascular Division Washington University School of Medicine St. Louis, MO 63110

Dr. Brown

David L. Brown, MD, FACC
Professor of Medicine
Cardiovascular Division
Washington University School of Medicine
St. Louis, MO 63110

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There is very little high quality data for use of IVC filters in general and no high quality data for using them in the population of patients who have had a DVT or PE and have a contraindication to anticoagulation.

However, this is the patient population for which filters are most commonly placed. Using administrative, observational data, we found that IVC filter placement in this all-comer population was associated with an increased risk of 30-day mortality after adjusting for baseline differences and immortal time bias. Continue reading

Cardiovascular Risks of Hormone Therapy in Transgender Individuals

MedicalResearch.com Interview with:

Michael Goodman, MD, MPH Professor of Epidemiology Director, MD/MPH program Emory University School of Public Health Atlanta, GA  30322

Dr. Goodman

Michael Goodman, MD, MPH
Professor of Epidemiology
Director, MD/MPH program
Emory University School of Public Health
Atlanta, GA  30322

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: There is a concern that hormone therapy may be associated with higher risk of certain cardiovascular problems such as heart attacks, stroke and formation of blood clots (“venous thromboembolism”).

To study this concern we examined data on 4,960 transgender and gender non-conforming people enrolled in Kaiser Permanente health systems in Georgia, Northern California, and Southern California. They were matched to 48,686 cisgender men and 48,775 cisgender women.  Below are the main findings

  • Rates of venous thromboembolism in all transwomen were approximately twice as high as the rates among cisgender men or cisgender women. The data for stroke and myocardial infarction demonstrated little difference between transwomen and cisgender men, but 80% to 90% higher rates among transwomen compared to cisgender women.
  • When the analyses focused specifically on transwomen who started therapy with female hormone estrogen at Kaiser Permanente, the incidence of both venous thromboembolism and stroke was more clearly elevated relative to either reference group.  There was evidence that incidence of both of these conditions among transwomen was particularly increased two to six years after estrogen initiation. By contrast, the association between estrogen therapy and myocardial infarction was less evident due to relatively few observed events.
  • Transmen did not appear to have significantly higher rates of venous thromboembolism, ischemic stroke, or myocardial infarction than their non-transgender counterparts, but this group was rather young and included a relatively small proportion of participants who initiated their hormone therapy during the study.

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Study Finds Direct Oral AntiCoagulants (DOACs) Safe in A Fib

MedicalResearch.com Interview with:

Yana Vinogradova, PhD, Research Fellow Division of Primary Care, School of Medicine University of Nottingham Nottingham

Dr. Vinogradova

Yana Vinogradova, PhD, Research Fellow
Division of Primary Care, School of Medicine
University of Nottingham
Nottingham

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Anticoagulants are prescribed for treatment and prevention of thrombosis and stroke but may lead to major bleeding.  Unlike the older drug warfarin, newer direct oral anticoagulants do not require regular blood tests but their safety was shown only in selected patients and in trial conditions.

The study found that Direct Oral AntiCoagulants (DOACs) are safer than warfarin in terms of bleeding risks with apixaban being the safest. 

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Venous Thromboembolism Prophylaxis Over & Underutilized in Some Hospitalized Patients

MedicalResearch.com Interview with:
Paul Grant, MD

Associate Professor of Medicine Associate Chief Medical Information Officer Director, Perioperative and Consultative Medicine Division of Hospital Medicine Department of Internal Medicine Michigan Medicine University of Michigan

Dr. Grant

Associate Professor of Medicine
Associate Chief Medical Information Officer
Director, Perioperative and Consultative Medicine
Division of Hospital Medicine
Department of Internal Medicine
Michigan Medicine
University of Michigan

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is well known that hospitalized medical patients are at risk for venous thromboembolism VTE, but the severity of patient risk can vary significantly. National guidelines have consistently stated that low-risk patients should not receive VTE prophylaxis beyond early ambulation.

In this retrospective cohort study, we analyzed data from 52 hospitals participating in the Michigan Hospital Medicine Safety consortium. Trained medical record abstractors at each hospital collected data from 44,775 medical patients including VTE risk factors, type of VTE prophylaxis administered, and contraindications to pharmacologic prophylaxis. Individual patient risk of VTE was determined using the Padua risk assessment model.

Of the 32,549 low-risk patients, 77.9% received excess venous thromboembolism prophylaxis as either pharmacologic prophylaxis (30.6%), mechanical prophylaxis (20.8%), or both (26.5%). In the 12,226 high-risk patients, VTE prophylaxis was underused in 22% of patients. The rates of inappropriate prophylaxis varied considerably by hospital.  Continue reading

Risk of Cancer Triples Following Blood Clot in Leg

MedicalResearch.com Interview with:
Dr. Jens Sundbøll
Department of Clinical Epidemiology
Aarhus University Hospital
Aarhus, Denmark

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The incidence of acute peripheral arterial occlusion is approximately 1.5 cases per 10,000 person-years. In comparison, the incidence rate of deep venous thrombosis is about 5-10cases per 10,000 person-years. It has been established previously that deep venous thrombosis in the lower limb and pulmonary embolism may be presenting symptoms of cancer and is associated with a poor cancer prognosis. However, whether arterial thromboembolism of the lower limb also can represent prodromal symptoms of occult cancer and worsen cancer prognosis has never been investigated.

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Varicose Veins Associated With Increased Risk of Deep Vein Blood Clots

MedicalResearch.com Interview with:

Shyueluen Chang

Shyueluen Chang

Shyueluen Chang MD
Phlebologist with Dermatologist background
Vein Clinic, Department of Dermatology,
Chang Gung Memorial Hospital
Taoyuan, Taiwan

MedicalResearch.com: What is the background for this study?  

Response: Varicose veins are common, with about 23 percent of U.S. adults having the condition, but they are rarely thought to be associated with serious health risks.

In contrast, venous thrombosis (DVT), pulmonary embolism (PE), and peripheral artery disease (PAD) are also vascular diseases that are associated with serious systemic effects. Not much is known about varicose veins and the risk of other vascular diseases. Elucidating potential associations between varicose veins and health-threatening diseases is important.

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Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty?

MedicalResearch.com Interview with:

Dr. David R. Anderson, MD, FRCPC, FACP Faculty of Medicine Dean, Professor Dean, Faculty of Medicine Division of Hematology, Department of Medicine  & Nova Scotia Health Authority

Dr. Anderson

Dr. David R. Anderson, MD, FRCPC, FACP
Faculty of Medicine Dean, Professor
Dean, Faculty of Medicine
Division of Hematology, Department of Medicine
& Nova Scotia Health Authority

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Blood clots in the lungs (pulmonary embolism) and veins of the legs (deep vein thrombosis) are well recognized complications following total hip and knee arthroplasty surgeries.  Prior to the routine use of antithrombotic prophylaxis, pulmonary embolism was the most common cause of death following these procedures.  Oral anticoagulants such as rivaroxaban are commonly prescribed for the indication of preventing blood clots following total hip or knee arthroplasty.  For maximal benefit these agents are continued following surgery for up to five weeks following total hip arthroplasty and for two weeks following total knee arthroplasty.

There is evidence that aspirin has some benefit for the prevention of deep vein thrombosis and pulmonary embolism following total hip or knee arthroplasty.  However there is less evidence for its benefit than for oral anticoagulants.  We reasoned that aspirin would potentially be an attractive alternative for extended out of hospital prophylaxis following total hip or knee arthroplasty for patients who received a short course (5 days )of rivaroxaban following surgery.  Aspirin would be attractive for this indication because of its low cost, ease of use, and low rates of side effects.

Our study demonstrated that in a randomized controlled trial involving a large group (over 3400) of patients undergoing total hip or knee arthroplasty that extended therapy with aspirin was comparable to rivaroxaban for the prevention of deep vein thrombosis and pulmonary embolism following surgery.  Low rates of complications (< 1%) were observed with both treatment arms.  We also found that rates of clinically important bleeding complications (the most common side effect with antithrombotic drugs) were uncommon and similar with the two agents.

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Standard or Low Dose Alteplase in Acute Ischemic Stroke–Does It Matter?

MedicalResearch.com Interview with:

Craig Anderson | MD PhD FRACP Executive Director  Professor of Neurology and Epidemiology, Faculty of Medicine, UNSW Sydney Neurologist, Neurology Department, Royal Prince Alfred Hospital The George Institute for Global Health at Peking University Health Science Center Haidian District | Beijing, 100088 P.R. China

Prof. Anderson

Craig Anderson | MD PhD FRACP
Executive Director
Professor of Neurology and Epidemiology, Faculty of Medicine, UNSW Sydney
Neurologist, Neurology Department, Royal Prince Alfred Hospital
The George Institute for Global Health at Peking University Health Science Center
Haidian District | Beijing, 100088 P.R. China

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:  There is much controversy over the benefits of a lower dose of intravenous alteplase, particularly in Asia, after the Japanese regulatory authorities approved a dose of 0.6 mg/kg 10 years ago compared to the US FDA and other regulatory authorities approving 0.9 mg/kg 20 years ago.  The investigator inititiated and conducted ENCHANTED trial aimed to determine the effectiveness and safety of these two doses in an international multicentre pragmatic open design.

The main results did not confirm the low-dose to be statistically ‘non-inferior’ partly due to the primary outcome measure chosen and partly due to the statistical approach, but it did confirm that the lower dose was safer with less risk of the major complication of this treatment, that of major bleeding in the brain.  However, it would appear that this safety effect was offset by some reduce efficacy in terms of functional recovery.

The aim of this secondary analysis of the trial data was to examine in more detail the differences between low and standard dose alteplase according to the participants’ age, ethnicity (Asian vs non-Asian) and severity of neurological deficit at the time of treatment.  We did this because the popular belief is that a lower dose might be preferred in older people, and Asians, because of the potential for more likelihood of bleeding, and preferentially to use the standard dose in those with more severe strokes potentially due to greater ‘clot burden’ from a blocked artery to the brain.

The results showed that the main findings on the outcome of surviving free of disability were the same according to age, ethnicity and stroke severity – that is, there was no preferential dose in any of these groups.  Similarly, the safety benefit of low dose alteplase on brain haemorrhage, did not clearly translate into clinical disability outcomes in any of the patient groups studied.

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Genetic Testing Reduces Risk Of Side Effects From Anticoagulation After Surgery

MedicalResearch.com Interview with:

Anne R. Bass, MD Associate Professor of Clinical Medicine Weill Cornell Medical College Rheumatology Fellowship Program Director Hospital for Special Surgery New York, NY 10021

Dr. Bass

Anne R. Bass, MD
Associate Professor of Clinical Medicine
Weill Cornell Medical College
Rheumatology Fellowship Program Director
Hospital for Special Surgery
New York, NY 10021

MedicalResearch.com: What is the background for this study?

Response: Blood thinners are used after orthopedic surgery to prevent blood clots from forming in the legs and traveling to the lungs. They are also used in patients with certain heart diseases to prevent strokes. Blood thinners, like warfarin, are effective but can be associated with serious bleeding complications, especially if the wrong dose is given. Genetic testing can help doctors predict the right warfarin dose to use in an individual patient.

In this trial, ≈1600 elderly patients undergoing hip or knee replacement were randomly assigned to receive warfarin dosing based on genetics plus clinical factors (like height, weight and gender), or based on clinical factors alone. The specific genes tested wereVKORC1, CYP2C9, and CYP4F2 which influence warfarin metabolism and the body’s ability to produce clotting factors.

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Phase 3 Study Finds XARELTO® Superior to Aspirin for Long-Term Prevention of Recurrent Blood Clots in VTE

MedicalResearch.com Interview with:

Paul Burton, MD, PhD, FACC Vice President, Medical Affairs Janssen

Dr. Paul Burton

Paul Burton, MD, PhD, FACC
Vice President, Medical Affairs
Janssen

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), affects more than 900,000 Americans each year; one-third of these occurrences are fatal. Once a person experiences a VTE, they are at risk of having another occurrence. Guidelines currently recommend anticoagulant therapy with a non-vitamin K antagonist oral anticoagulant (NOAC), like XARELTO® (rivaroxaban), for three months or longer. Once anticoagulant therapy is stopped, up to 10 percent of people will experience a recurrence during the first year and up to 20 percent within three years. In people who decide to stop anticoagulant therapy, guidelines currently suggest using aspirin for long-term prevention of recurrent VTE rather than no aspirin at all.

The Phase 3 EINSTEIN CHOICE study was designed to compare the efficacy and safety of XARELTO® to aspirin for continued VTE management in people who experienced an initial VTE. The study met its primary endpoint, finding both XARELTO® doses (10 mg or 20 mg once daily) to be superior to aspirin 100 mg once daily in preventing recurrent VTE, with no significant impact on safety. Specifically, XARELTO® 10 mg reduced the risk of recurrent VTE by 74 percent and XARELTO® 20 mg by 66 percent. Rates of major bleeding were comparable and low across all treatment groups.

These results were presented at the American College of Cardiology’s 64th Annual Scientific Session (ACC.17) during a Joint ACC/Journal of American Medical Association Late-Breaking Clinical Trials session and published simultaneously in The New England Journal of Medicine.

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Computerized Clinical Decision Support Systems Can Reduce Rate of Venous Thromboembolism

MedicalResearch.com Interview with:
Zachary Borabm, Research fellow

Hansjörg Wyss Department of Plastic Surgery
NYU Langone Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Recent studies have shown that health care providers perform poorly in risk stratifying their patients for venous thromboembolism (VTE) which leads to inadequate VTE prophylaxis delivery, especially in surgical patients. Computerized Clinical Decision Support Systems (CCDSSs) are programs integrated into an electronic health record that have the power to aid health care providers. Using a meta-analysis study technique we were able to pool data from 11 studies, including 156,366 patients that either had CCDSSs intervention or routine care without CCDSSs.

Our main outcome measures were the rate of prophylaxis for VTE and the rate of actual VTE events. We found that CCDSSs increased the rate of VTE prophylaxis (odds ratio 2.35, p<0.001) and decreased the risk of VTE events (risk ratio 0.78, p<0.001).

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Pradaxa: Compared To Warfarin, Lower Risk of Stroke and Bleeding in Non-Valvular AFib

MedicalResearch.com Interview with:

Sabine Luik, M.D. Senior vice president, Medicine & Regulatory Affairs Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Sabine Luik

Sabine Luik, M.D.
Senior vice president, Medicine & Regulatory Affairs
Boehringer Ingelheim Pharmaceuticals, Inc.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Data from more than 20,000 patients with non-valvular atrial fibrillation (NVAF) were included in this study and the results demonstrate that Pradaxa® (dabigatran etexilate mesylate) was associated with a lower risk of stroke and major bleeding compared to warfarin. The study analyzed 7,245 PRADAXA patients and 14,490 warfarin patients with NVAF who had no prior use of an oral anticoagulant (OAC), using data from an administrative claims database from October 1, 2010, to April 30, 2014.

Compared to warfarin, PRADAXA was associated with a 26 percent reduced risk of stroke (HR, 0.74; 95% Cl, 0.58-0.94) and a 20 percent reduced risk of major bleeding (HR, 0.80; 95% Cl, 0.69-0.92). PRADAXA was associated with a lower risk for serious secondary outcomes, including a 68 percent reduced risk of hemorrhagic stroke (HR, 0.32; 95% Cl, 0.14-0.76), an 18 percent reduced risk of major extracranial bleeding (HR, 0.82; 95% Cl, 0.70-0.96), a 48 percent reduced risk of venous thromboembolism (HR, 0.52; 95% Cl, 0.38-0.70), and a 27 percent reduced risk of death (HR, 0.73; 95% Cl, 0.61-0.88).

MedicalResearch.com: What should readers take away from your report?
Response: These results support the benefits of PRADAXA therapy for patients with NVAF and are consistent with those of previous studies evaluating PRADAXA and warfarin. Through a robust clinical trial, Pradaxa was proven superior to warfarin in reducing the risk of stroke in patients with NVAF.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Real-world data are critical for improving our understanding of treatment for patients with chronic conditions such as NVAF. We believe by working with diverse stakeholders to continue to study PRADAXA in the real world, we can help the community better understand gaps in treatment, identify opportunities to improve care and increase patient and physician assurance in treatment decisions.

MedicalResearch.com: Is there anything else you would like to add?

Response: Pradaxa has the longest real-world experience of any available NOAC. This research includes seven clinical trials with more than 32,000 patients and real-world experience through 11 studies and assessments, including more than 120,000 PRADAXA patients with NVAF.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

INTERNATIONAL STROKE CONFERENCE ORAL ABSTRACTSSESSION TITLE: PREVENTIVE STRATEGIES ORAL ABSTRACTS
Abstract 75: Bleeding and Ischemic Stroke Risk in Patients with Atrial Fibrillation Standard or Low Dose Dabigatran and Concomitant P-gp Inhibitors
Mary Vaughan Sarrazin, Alexander Mazur, Michael P Jones, Elizabeth Chrischilles
Stroke. 2017;48:A75

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

More Medical Research Interviews on MedicalResearch.com

Statins Linked to Reduced Risk of Venous Thromboembolism

MedicalResearch.com Interview with:

Setor Kunutsor BSc MD MPhil(cantab) PhD(cantab) Research Fellow/Epidemiologist Musculoskeletal Research Unit University of Bristol School of Clinical Sciences Learning & Research Building (Level 1) Southmead Hospital

Dr. Setor Kunutsor

Setor Kunutsor BSc MD MPhil(cantab) PhD(cantab)
Research Fellow/Epidemiologist
Musculoskeletal Research Unit
University of Bristol
School of Clinical Sciences
Southmead Hospital

MedicalResearch.com: What is the background for this study?

Response: Statins are well established for the prevention of cardiovascular disease and this is based on their ability to lower levels of circulating lipids in the blood. However, statins are also known to have pleotropic effects and these include potential protective effects on multiple disease conditions.

Based on their anti-inflammatory and antithrombotic properties, there have been suggestions that statins may prevent venous thromboembolism (VTE) (which comprises of pulmonary embolism and deep vein thrombosis). The evidence is however uncertain. Several studies utilizing both observational cohort and randomized controlled designs have been conducted to evaluate whether statin therapy or use is associated with a reduction in the incidence of VTE, but the results have been inconclusive. In a recent review that was published in 2012, Rahimi and colleagues pooled the results of several randomized controlled trials (RCTs), but found no significant reduction in the risk of VTE with statin therapy [REF]. Given the publication of new studies since this study was published and the existing uncertain evidence on the effect of statins on VTE, we decided it was time to bring all the evidence together and evaluate if statin therapy really did have a protective effect on the risk of venous thromboembolism.

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Only High Risk Patients May Require Anticoagulation After Arthroscopic Knee Surgery

MedicalResearch.com Interview with:

Suzanne C. Cannegieter, M.D., Ph.D. Einthoven Laboratory  Leiden University Medical Center  The Netherlands

Dr. Suzanne Cannegieter,

Suzanne C. Cannegieter, M.D., Ph.D.
Einthoven Laboratory
Leiden University Medical Center
The Netherlands

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Patients who undergo arthroscopic knee surgery and patients who are treated with casting of the lower leg are at increased risk for venous thromboembolism (VTE). It is uncertain whether thromboprophylaxis is effective in these situations to prevent VTE. For both indications, several trials have been performed to evaluate the effectiveness of anticoagulant prophylaxis. However, an overall risk–benefit balance could not be established because of methodologic shortcomings; hence, there has been reluctance to establish international guidelines regarding the use of anticoagulant therapy for either of these indications.

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Starting Testosterone Associated With Increased Risk of Blood Clots

MedicalResearch.com Interview with:
Dr. Carlos Martinez

Institute for Epidemiology, Statistics and Informatics GmbH
Frankfurt, Germany,

MedicalResearch.com: What is the background for this study?

Response: A 10-fold increase in testosterone prescriptions per capita in the United States and a 40-fold increase in Canada in men has occurred over the first decade of this century, mainly for sexual dysfunction and/or decreased energy. Recognised pathological disorders of the male reproductive system remain the sole unequivocal indication for testosterone treatment but there has been increasing use in men without pathological hypogonadism. A variety of studies and meta-analyses have provided conflicting evidence as to the magnitude of the risk of cardiovascular events including venous thromboembolism in men on testosterone treatment.

In June 2014, the US Food and Drug Administration and Health Canada required a warning about the risk of venous thromboembolism to be displayed on all approved testosterone products. Studies have reported contradictory results on an association between testosterone use and the risk of venous thromboembolism. The effect of timing and duration of testosterone use on the risk of venous thromboembolism was not studied and may explain some of these contradictory findings.

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Peripheral IV Lines Linked To Lower Risk of Blood Clots After Transfusion

MedicalResearch.com Interview with:
Mary A.M. Rogers, PhD, MS

Research Associate Professor
Research Director, Patient Safety Enhancement Program
Department of Internal Medicine
University of Michigan
Ann Arbor, MI

MedicalResearch.com: What is the background for this study?

Response: Peripherally inserted central catheters (PICCs) are commonly used for vascular access in hospitalized patients. Previous studies have shown that PICCs of larger gauge (diameter) increase the risk of developing venous thromboembolism (blood clots in the deep veins that sometimes travel to the lung). Red blood cell transfusion is also known to increase the risk of venous thromboembolism. Because PICCs are often used to transfuse blood, we designed a study to investigate whether the method of transfusion delivery influences the risk of developing venous thromboembolism.

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Laser-Assisted Technology Allows Easier Removal of IVC Filters

MedicalResearch.com Interview with:

William T. Kuo, MD, FSIR, FCCP, FSVM Director, Stanford IVC Filter Clinic Director, IR Fellowship Program Founding Director, IR-DR Residency Program Associate Professor, Interventional Radiology Stanford University Medical Center Stanford, CA

Dr. William T. Kuo

William T. Kuo, MD, FSIR, FCCP, FSVM
Director, Stanford IVC Filter Clinic
Director, IR Fellowship Program
Founding Director, IR-DR Residency Program
Associate Professor, Interventional Radiology
Stanford University Medical Center
Stanford, CA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In the USA, over 250,000 IVC filters are now implanted each year, and rising filter use has led to an increase in filter-related morbidity and recognition of the potential complications from indwelling IVC filters. Consequently, the FDA has issued two safety communications alerting all physicians caring for patients with IVC filters to consider removing the filter as soon as protection from pulmonary embolism is no longer needed:

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm?so urce=govdelivery&utm_medium=email&utm_source=govdelivery

Despite heightened awareness, up to 40-60% of IVC filters cannot be easily removed using standard methods alone, after the filter becomes firmly embedded. Additionally, many patients have undergone prior placement of a permanent-type filter not even designed for retrieval, leaving them with few options for safe device removal. Although all of these patients can develop filter-related morbidity especially after chronic implantation, there is currently no routine option for removing embedded IVC filters refractory to standard retrieval methods. Our 5-year first-in-human study of a novel procedure—laser-assisted filter removal— demonstrates the safety and efficacy of this technique to treat such patients. In a cohort refractory to standard retrieval methods and high force, endovascular laser-assisted retrieval was overall safe and successful in removing a variety of filter types including permanent filters, regardless of dwell time and without the need for open surgery.

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Shorter Hospital Stays and Lower Costs for Rivaroxaban Compared With Warfarin for Venous Thrombosis Admissions

MedicalResearch.com Interview with:
Truven Health AnalyticsJay Margolis, PharmD
Sr. Research Scientist
Truven Health

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Vitamin K antagonists (VKAs), most commonly warfarin, had been the only orally available anticoagulants available for the last 60 or so years. While highly effective, use of these agents was often problematic due to their narrow therapeutic index, need for routine coagulation monitoring, and interactions with food and other drugs. Recently introduced new oral anticoagulants (NOACs), particularly rivaroxaban, had been shown in clinical trials to provide comparable efficacy to the VKAs without the need for routine coagulation monitoring. There have been few studies outside of clinical trials showing benefits that translate to real-world populations.

In our study using real-world data from a large sample of geographically and demographically diverse US hospitals, patients hospitalized for incident venous thromboembolisms (VTE) initiating oral anticoagulant treatment with rivaroxaban had significantly shorter hospital stays and lower hospitalization costs compared with warfarin-treated patients.

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Use of Oral Anticoagulation at Time of PCI Surgery Linked To Increase in Adverse Events

MedicalResearch.com Interview with:

Eric A. Secemsky, MD MSc Interventional Cardiology Fellow Massachusetts General Hospital, Harvard Medical School Fellow, Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center

Dr. Eric A. Secemsky

Eric A. Secemsky, MD MSc
Interventional Cardiology Fellow
Massachusetts General Hospital
Harvard Medical School
Fellow, Smith Center for Outcomes Research in Cardiology
Beth Israel Deaconess Medical Center

MedicalResearch.com: What is the background for this study?

Response: Use of oral anticoagulant (OAC) therapy prior to coronary stenting is a significant predictor of post-procedural bleeding events. Previous studies have estimated that the frequency of chronic OAC use among patients undergoing percutaneous coronary intervention (PCI) is between 3% to 7%. Yet many of these analyses examined select patient populations, such as those admitted with acute myocardial infarction or atrial fibrillation, and preceded the market approval of non-vitamin K antagonist oral anticoagulants (NOACs). As such, the contemporary prevalence of OAC use among all-comers undergoing PCI, as well as associated risks of adverse events, are currently unknown.

Therefore, we used PCI data from a large, integrated healthcare system to determine current use of  oral anticoagulant use among all-comers undergoing coronary stenting and the related short- and long-term risks of therapy.

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Mechanism of Injury Makes A Difference In Risk of Venous Thromboembolism

MedicalResearch.com Interview with:
Charles A. Karcutskie IV, MD, MA

Postdoctoral Research Fellow
University of Miami Miller School of Medicine
Department of Surgery
Divisions of Trauma, Surgical Critical Care, and Burns

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our research group at the Ryder Trauma Center have recently done several studies showing various differences in outcomes and risk based on mechanism of injury. Additionally, venous thromboembolism (VTE) is another topic that our group has focused on in the past several years. Because trauma patients are inherently at a higher risk for VTE due to the nature of their injury, we questioned whether the most important risk factors for VTE were different after blunt or penetrating trauma. At our institution, we assess VTE risk with the Greenfield Risk Assessment Profile, which is a list of several risk factors that each have weight toward an overall risk score. We took these risk factors and analyzed them individually based on mechanism of injury. We found that the factors that contribute to the VTE risk are different based on injury mechanism: After blunt trauma, transfusion status, neurologic status, and pelvic fracture contributed most. After penetrating trauma, vascular injury, severe abdominal injury, and age 40-59 years contributed most. This tells us that mechanism of injury may need to be incorporated into the risk assessment in order to discover the highest risk patients.

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